The Impact of Landscape Changes on Data and Safety Monitoring Board Oversight of Clinical Trials.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 38319813.
- Also identified by DOI 10.1056/EVIDctw2100019.
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Abstract
Impact of Landscape Changes on DSMB OversightThis Clinical Trials Workshop describes how external factors (or landscape changes) can affect monitoring of an ongoing clinical trial and discusses issues to consider to avoid stopping a trial too early while maintaining equipoise for enrolled participants. Three clinical trials in which DSMBs had to consider the effects of landscape changes on the continued performance of the monitored trial are reviewed.
Medical subject headings
- Clinical Trials Data Monitoring Committees